Ulcerative colitis - Colitis ulcerosa Chemoprevention - Chemopreventie Colorectal cancer - Colorectaal carcinoom
Conditions
Interventions
There are three groups:
1. This group will receive 5-ASA: 4 g a day (4 sachets of 1000mg granu-stix) and UDCA 20-25 mg/kg/day (500mg tablets)
2. This group will receive 5-ASA: 4 g a day (4 sachets of 1000mg granu-stix) and a placebo of UDCA 20-25 mg/kg/day(500mg tablets)
3. This group will receive a placebo of 5-ASA: 4 g a day (4 sachets of 1000mg granu-stix) and a placebo of UDCA 20-25 mg/kg/day (500mg tablets).
Medication will be used during 1 year.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical activity index ¡Ü 4; 2. Long-standing extensive ulcerative colitis for more than 8 years; 3. Age 18-65 years; 4. Using 6-mercaptopurine or azathioprine to maintain remission; 5. For women only: sufficient anti-conception; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Dysplasia or colorectal cancer before study entry; 2. Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection); 3. Colectomy; 4. Family history of colorectal cancer; 5. Symptomatic cholelithiasis; 6. Cholecystitis; 7. Coagulation disorder or use anticoagulants that can not be temporarily discontinued, precluding the taking of biopsies; 8. Chronic renal impairment/failure; 9. Diabetes mellitus (higher risk for developing renal disease); 10. Hypertension (higher risk for developing renal disease); 11. Allergy to 5-ASA or UDCA; 12. Vertricular/gastric or duodenal ulcera; 13. Asthma; 14. For women only: Pregnancy, lactation or childbearing potential without adequate contraception; 15. Galactose-intolerance, Lapp lactasedeficience or glucose-galactose malabsorption; 16. Treatment with antacids containing hydroxide, hypolipidemics, high-dose calcium supplements (¡Ý 1200 mg/day), or any other medication disturbing the enterohepatic circulation; 17. Treatment with methotrexate, riphampicine, lactulose or glucocorticosteroids; 18. Unwillingness to be informed about accidental diagnostic findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, relative to the placebo group; 2. Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by genome-wide array based mRNA expression analysis of UC normal colonic mucosa before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF size and rate of dysplasia, relative to the placebo group; 2. Improve understanding of early events in colorectal carcinogenesis by genome-wide array based mRNA expression analysis of dysplastic ACF and UC normal colonic mucosa. | — |
Contacts
Public ContactA.M. Leufkens
Postbus 85500, F 02.618
Outcome results
None listed